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BLOOD GLUCOSE

MONITORING SYSTEM

OWNER'S
MANUAL
311-4255100-001
Version 1.0 Octorber, 2008

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  • Page 1: Monitoring System

    BLOOD GLUCOSE MONITORING SYSTEM OWNER’S MANUAL 311-4255100-001 Version 1.0 Octorber, 2008...
  • Page 2 UltraTRAK PRO also has a top-loading strip port with strip ejection capabilities, ensuring optimal safety for healthcare providers and convenience. The strip eject function elimi-...
  • Page 3 vertex diagnostics www.vertexdiagnostics.com IMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USING The following basic safety precautions should always be taken. Close supervision is necessary when the device is used by, on, or near children, handicapped persons or invalids. Use the device only for the intended use described in this manual.
  • Page 4: Table Of Contents

    Appearance and Key Function of the Meter LCD Display Appearance of the Test Strip PREPARATIONS BEFORE USE Battery Replacement Setting the Meter and Deleting the Memory Alarm Function BEFORE TESTING Checking with UltraTRAK PRO Control Solutions Important Control Solution Information Doing a Control Solution Test...
  • Page 5 vertex diagnostics www.vertexdiagnostics.com TESTING YOUR BLOOD Test Procedure Expected Test Results COMPARING METER AND LABORATORY RESULTS USING THE METER MEMORY Viewing Results on the meter Viewing Results on a Personal Computer TAKE CARE OF YOUR METER AND STRIP Cleaning Storage PROBLEM-SOLVING GUIDE Special Message Error Message...
  • Page 6: Important Information

    IMPORTANT INFORMATION Severe dehydration and excessive water loss may ¾ cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare profes- sional immediately. If you get your blood glucose results lower or higher ¾ than usual, and do not have symptoms, first repeat the test.
  • Page 7: About Alternative Site Testing (Ast)

    Alternate site testing (AST) means that people use parts of the body other than fingertips to check their blood glucose levels. UltraTRAK PRO Test Strips allow you to test on the palm, the forearm, the upper arm, the calf, and the thigh...
  • Page 8 We strongly recommend you do AST in the following intervals: In a pre-meal or fasting state (more than 2 hours since ¾ the last meal). Two hours or more after taking insulin. ¾ Two hours or more after exercise. ¾ Do NOT use AST if: you think your blood glucose is low.
  • Page 9: Getting Started

    vertex diagnostics www.vertexdiagnostics.com GETTING STARTED Intended Use ” The system is intended for use outside the body (in vitro diagnostic use). It should be used only for testing glucose (sugar) and only with fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh).
  • Page 10: Contents Of The System

    Contents of the System ” These products included in the kit have been designed, tested, and proven to work together as a system to pro- duce accurate blood glucose test results. Use only the same brand-name test strips and a control solution with the blood glucose meter.
  • Page 11: Appearance And Key Function Of The Meter

    vertex diagnostics www.vertexdiagnostics.com Appearance and Key Function of the Meter ” 1.TEST SLOT 2.LCD DISPLAY 3.STRIP-EJECTION BUTTON 6.BATTERY COMPARTMENT 4.MAIN BUTTON 5.SET BUTTON 1. TEST SLOT Is where you insert the test strip. The meter will turn on automatically after insertion. 2.
  • Page 12: Lcd Display

    LCD Display ” Blood Drop Symbol Flashes when it is ready to apply the sample. Test Strip Symbol Test Result Area Appears when the meter is Displays glucose results. turned on. A decimal point appears when the measurement unit is mmol/L. Measurement Unit Ketone Warning Appears with the test...
  • Page 13: Appearance Of The Test Strip

    vertex diagnostics www.vertexdiagnostics.com Appearance of the Test Strip ” This system measures the amount of sugar (glucose) in whole blood. Blood is applied to the absorbent hole of the test strip and is automatically drawn into the reaction cell where the reaction takes place. The test strip consists of the following parts: Contact Bars Insert this end of the test strip into the meter.
  • Page 14: Preparations Before Use

    PREPARATION BEFORE USE Battery Replacement ” Your meter comes with two 1.5V AAA alkaline batteries. The meter will alert you when the power is getting low by displaying two different messages: When symbol appears on the display: the meter is functional and the result re- mains accurate, but it is time to change the battery.
  • Page 15 vertex diagnostics www.vertexdiagnostics.com To replace the battery, make sure that the meter is turned off. STEP1 Press the buckle on battery cover and lift up to remove cover. STEP2 Remove the old battery and replace with two 1.5V AAA alkaline batteries. STEP3 Close the battery cover.
  • Page 16: Setting The Meter And Deleting The Memory

    Setting the Meter and Deleting the Memory ” Your meter comes with the time, date, unit of measurement, memory deletion and alarm function setting. If you need to set these parameters, please follow below steps. Start with the meter off. Then press the set button located in the bat- tery compartment.
  • Page 17 vertex diagnostics www.vertexdiagnostics.com STEP 2 Set the Month Press and release the main button until you see the correct month. To move faster, keep pushing the main button down. When the de- sired month is displayed, press the set button and then the day will flash.
  • Page 18 If you select 24h, format of time will be from 00:00 to 23:59 without AM and PM. An example is shown below. 10 o’clock in the moming 10 o’clock in the evening After finishing setting 12h or 24h, press the set button and then the hour will flash on the screen.
  • Page 19 vertex diagnostics www.vertexdiagnostics.com STEP 6 Set the Minutes Press and release the main button to advance one minute. To move faster, keep pushing the main but- ton down. When the desired minute is displayed, press the set button and then the current unit of mea- surement will flash.
  • Page 20 STEP 8 Delete Memory “dEL” and flashing yes/no is displayed on the screen. If you do NOT want to delete memory, press the main button to select “no” and then press set button to go to step 9. If you’d like to delete ALL memory, press main button to select “yes”.
  • Page 21 vertex diagnostics www.vertexdiagnostics.com STEP 9 Select and Set Alarm Function The meter provides four alarms. You are able to set four different alarming times a day. Flashing “On” or “OFF” and “ ” are displayed on the screen firstly. Press the main button to turn on or turn off Alarm 1.
  • Page 22 Alarm 2 setting If you press the main button to select “OFF”, then press the set button to go to set Alarm 2. If you press the main button to select “On”, then press set button to set hour. Set hour and minute according to the instruction described in Alarm 1.
  • Page 23 vertex diagnostics www.vertexdiagnostics.com Alarm 3 setting If you press the main button to select “OFF”, then press the set button to go to set Alarm 4. If you press the main button to select “On”, then press set button to set hour. Set hour and minute according to the instruction described in Alarm 1.
  • Page 24 Alarm 4 setting If you press the main button to select “OFF”, press the set button to turn off the meter. If you press the main button to select “On”, then press set button to set hour. Set hour and minute according to the instruction described in Alarm 1.
  • Page 25: Alarm Function

    vertex diagnostics www.vertexdiagnostics.com Alarm Function The meter provides for alarms. The alarm function alerts you to perform your blood glucose regularly. If you need to set alarm function, please refer to page19 " Select and Set Alarm Function" for information. If you have turned on the alarm function, the meter will auto-start in the time point you set with short beeps for two minutes.
  • Page 26 An example if Alarm 1 at 10:00AM and Alarm 2 at 2:00PM. The meter automatically turns on at 10:00 AM first and next turns on at 2:00 PM. You can directly insert a new strip to perform a test. If you don’t want to perform a test after the meter turns on: ►Press the main button.
  • Page 27 vertex diagnostics www.vertexdiagnostics.com ►Or you can leave the meter without pressing any button for two minutes. The meter will turn off automatically PLEASE NOTE! • If the alarm function is set, the alarm symbol will appear on the screen when the meter is off. •...
  • Page 28: Before Testing

    BEFORE TESTING Checking with UltraTRAK PRO Glucose Control Solution ” UltraTRAK PRO glucose control solutions contain a known amount of glucose that reacts with test strips. By comparing your control solution test results with the expected range printed on the...
  • Page 29 vertex diagnostics www.vertexdiagnostics.com • When your test strips are exposed to extreme environmental conditions (See Storage section of this manual). • When you want to practice running the test. • If you drop the meter.
  • Page 30: Important Control Solution Information

    Important Control Solution Information ” • Use only UltraTRAK PRO control solutions. • Check the expiration date on the control solution vial. Do not use if expired. • Control solution, meter, and test strips should come to room temperature 68°F to 77°F(20°C to 25°C) before testing.
  • Page 31: Doing A Control Solution Test

    vertex diagnostics www.vertexdiagnostics.com Doing a Control Solution Test ” STEP 1 Insert the Test Strip Insert a test strip with contact bars end first and facing up, into the test slot. The meter turns on automatically and displays the followings in sequence: →...
  • Page 32 WARNING • Contact bars must be inserted all the way into the meter or you may get an inaccurate test result. • Every time you perform a control solution test, you must enter into the “QC” test mode and then the test result with “QC” symbol will be stored in the meter memory.
  • Page 33 vertex diagnostics www.vertexdiagnostics.com STEP 3 Obtain Control Solution. Shake the control solution vial well. Remove the cap from the control solution bottle. Place cap on flat surface. Squeeze the vial, discard the first drop, and wipe off the dispenser tip to prevent contamination. Squeeze the vial again to get another drop and apply the drop to the top of cap.
  • Page 34 STEP 5 . Read and Compare the Result After counting to 0, the test result of control solution is shown on the screen.Compare this result with the range printed on the test strip vial. It should fall within this range. Out-of-range results If test results fall outside the range printed on the test strip vial, check the section of “Problem in Operation”...
  • Page 35: Testing Your Blood

    vertex diagnostics www.vertexdiagnostics.com TESTING YOUR BLOOD Be sure to read this section and the test strip package insert found in the test strip box carefully before testing. Make sure you have all items needed to test: A.Blood Glucose Meter B.Test Strip C.Lancing Device D.Sterile Lancet E.Clear Cap (For AST use)
  • Page 36 Testing Procedure ” Wash and dry your hands first before starting. STEP 1 Set the Lancing Device. Screw off the cap of lancing device. Insert a lancet into the lancet holder and push down firmly until it is fully seated. Twist the protective disk until it separates from the lancet.
  • Page 37 vertex diagnostics www.vertexdiagnostics.com Slide the ejection/cocking control back until it clicks. If it does not click the device may have been cocked when the lancet inserted. • Blood from sites other than the fingertip A clear cap, together with the kit, makes it easier to get a drop of blood for AST.
  • Page 38 STEP 2 Insert Test Strip Insert a test strip with contact bars end first and facing up into the test slot. The meter turns on automatically and displays the followings in sequence:  ”CHk” and ” ”  ambient temperature , flashing and "Gen"...
  • Page 39 vertex diagnostics www.vertexdiagnostics.com Sites other than fingertip ¾ Please refer to the section of “About AST” for available punctured sites. After penetration, discard the first drop of blood with a clean tissue paper or cotton. Then gently squeeze the punctured area to obtain blood.
  • Page 40 STEP 4 Apply Blood into the Test Strip When “ “ is flashing on the screen, apply your blood to the absorbent hole of the test strip until the confirmation window is fully filled with blood. The me- ter then begins to count down automatically.
  • Page 41 vertex diagnostics www.vertexdiagnostics.com PLEASE NOTE! • Do not push your finger (with blood on it) against the test strip or try to apply a smeared sample on the test strip. • If you do not apply a blood sample to the test strip within 3 minutes, the meter will automatically turn off.
  • Page 42 STEP 6 Eject the Used Test Strip After finishing the measurement, you can either take out the used strip by simply pushing up the Strip-Ejection button or remove the test strip directly by your hand. “OFF” is shown after the used strip is ejected and the meter will shut off automatically afterward.
  • Page 43: Expected Test Results

    60%* . The results you get with the UltraTRAK PRO system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.
  • Page 44 COMPARING METER AND LABORATORY RESULTS The meter provides you with whole blood equivalent results. The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter results can be affected by factors and conditions that do not affect laboratory results in the same way (See test strip package insert for typical accuracy and precision data, and for important information on Limitations).
  • Page 45 vertex diagnostics www.vertexdiagnostics.com You may still have a variation from the result because blood glucose levels can change significantly over short periods, especially if you have recently eaten, exercised, taken medication, or experienced stress* . In addition, if you have eaten recently, the blood glucose level from a finger stick can be up to 70 mg/dL (3.9 mmol/L) higher than blood drawn from a vein (venous sample) used for a lab test*...
  • Page 46: Using The Meter Memory

    USING THE METER MEMORY View Results on the Meter ” Your meter stores the latest 450 results of control solution and your blood glucose with date and time in its memory. It also automatically calculates the averages of your blood glucose in the intervals of 7, 14, 21, 28, 60 and 90 days.
  • Page 47 vertex diagnostics www.vertexdiagnostics.com STEP 3. After the last test result, press the M button again and the meter will be turned off. 2. Read the Average of Blood Glucose Results: STEP 1. When the meter is off, press and release the main button.
  • Page 48 The 7- day average is calculated from the blood glucose results obtained during the last 7 days.  The average of glucose tests.  The average was calculated from the test results of the last 14 days.  106 glucose tests have been performed in the last 14 days.
  • Page 49 vertex diagnostics www.vertexdiagnostics.com STEP 3. Exit The Memory Mode After the 90-day average, press the main button again to turn off the meter. PLEASE NOTE! 1.When pressing the main button to recall the stored test results, blinking “ ” will be displayed on the main screen first.
  • Page 50 2. When using the meter for the first time, “---“ is displayed when you recall the test results or review the average result. It means that there is no test result in memory. 3. Anytime when you want to exit the memory, keep press- ing the main button for 5 second until “OFF”...
  • Page 51 Health Care System Software and an Interface Cable are required before installation. The software can be downloaded from the home page of Vertex Diagnostics (www.vertexdiagnostics.com). The interface cable is an op- tional accessory. To learn more about Health Care System Software or to obtain an Interface Cable separately, please contact your local customer care line.
  • Page 52 Step 3 Transmit Data Follow the instructions provided in the software to transmit data. Results transmitted will include date and time. Remove the cable and the meter will automatically turn off. PLEASE NOTE! While the meter is connected to the PC, it is unable to perform a blood glucose test.
  • Page 53 vertex diagnostics www.vertexdiagnostics.com TAKE CARE OF YOUR METER AND STRIP To avoid the meter and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use. Cleaning ” To clean the meter exterior, wipe with a cloth moist- ened with tap water or a mild cleaning agent, then dry the device with a soft and dry cloth.
  • Page 54 2. Strip Storage Storage condition: 40°F to ¾ 140°F (4°C to 40°C), below 85% relative humidity. Do not freeze. Store your test strips in their ¾ original vial only. Do not transfer to other container. Store test strip packages in ¾...
  • Page 55: Control Solution Storage

    vertex diagnostics www.vertexdiagnostics.com Use each test strip immediately ¾ after removing it from the vial. Write the discard date (the ¾ date opened plus 90 days) on the vial label when you first open it. Discard remaining test strips 90 days after first open- ing date.
  • Page 56 PROBLEM-SOLVING GUIDE The “Error Messages” you will probably encounter when using this meter are listed as followings. If you get any problem in performing test with this meter, please refer to the following problem-solving guides. These guides help you to identify and solve certain problems, but not in all circumstances.
  • Page 57: Special Message

    vertex diagnostics www.vertexdiagnostics.com Special Message ” Special symbols and messages appear together with your test result. Message What it means appears when your result is below 20 mg/dL (1.1 mmol/L). is shown when your result is equal or KETONE? higher than 240 mg/dL (13.3 mmol/L). This indi- cates the possibility of ketone accumulation for Type 1 diabetes.
  • Page 58: Error Message

    Error Message ” Message What it means Action Appear when the battery Replace the battery can not provide enough immediately. power for a test. Appear when inserting a Test with a new test used test strip. strip. Appear when environmental System operation temperature is below system range is 50 to 104°F...
  • Page 59: Problem In Operation

    vertex diagnostics www.vertexdiagnostics.com Problem in operation ” 1. If the meter does not display a message after inserting a test strip: PROBABLE CAUSE WHAT TO DO Battery exhausted. Replace the battery. Battery incorrectly installed or Check that the battery is correctly absent.
  • Page 60 3. If the control solution test result is out of range PROBABLE CAUSE WHAT TO DO Read the instruction thor- Error in performing the test. oughly and repeat the test again. Shake the control solution Do not shake the control vigorously and repeat the solution vial very well.
  • Page 61: Specifications

    vertex diagnostics www.vertexdiagnostics.com SPECIFICATIONS Dimension & Weight: 61.7mm(L) x 92.7mm(W) x 23.2mm(H), 79.97g Power source: two 1.5V AAA alkaline batteries Memory: 450 measurement results and control solution tests with date and time Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down Auto turn-off after 3 minutes without action Temperature warning...
  • Page 62: Summary Of Operation

    SUMMARY OF OPERATION This summary is intended only for quick reference and not as a substitute for the owner’s manual. Please read the entire manual before you begin testing. STEP1. Insert test strip The meter is automatically turned on. The room temperature is also displayed. STEP2.
  • Page 63 vertex diagnostics www.vertexdiagnostics.com STEP4. STEP4. Obtain a result The meter starts to count down. Never try to add any blood into the absorbent hole even if you find that the confirmation window is not completely filled. Discard the strip and retest with a new strip. STEP 5 Eject the used strip by pushing the strip-ejec- tion button.
  • Page 64 Distributed by: Vertex Diagnostics 958 Church St. Baldwin, NY 11510 Customer Care Line: 1.888.90.VERTEX Customer Service Line is available for 24 hours, 7 days a week.
  • Page 65 vertex diagnostics www.vertexdiagnostics.com...
  • Page 67 vertex diagnostics www.vertexdiagnostics.com...

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